Clofarabine and Low Dose Total Body Irradiation as a Preparative Regimen for Stem Cell Transplant in Leukemia.
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
Stem cell transplant is an important therapeutic option for pediatric patients with relapsed
or refractory leukemia. Although, full myeloablative transplants are widely used for patients
with acute leukemia, myeloablative chemo-radiotherapy may not be feasible in some specific
settings. These settings include 1) patients with pre-existing health issues and organ
toxicities; 2) patients who have relapsed post-ablative transplant and need a second stem
cell transplant; and 3) leukemia patients with advanced disease who have been heavily
pre-treated. Clofarabine, a new purine nucleoside anti-metabolite, has the advantage of
significant antileukemic activity in addition to its possible immuno-suppressive properties.
In this study we plan to determine the maximum feasible dose (MFD) of Clofarabine in
combination with total body irradiation that can achieve durable donor engraftment without
causing excessive toxicity.
Phase:
Phase 1
Details
Lead Sponsor:
Therapeutic Advances in Childhood Leukemia Consortium